Dr. Lei Xu: Neurofibromatosis 2 is characterized by benign tumors that develop throughout the nervous system. The most common site of these tumors is the eighth cranial nerve, which carries hearing and balance information from the ears to the brain. Although these vestibular schwannomas grow slowly, they usually lead to a significant or total hearing loss by young adulthood or middle age. The tumors can also press on the brain stem, leading to headaches, difficulty swallowing and other serious neurologic symptoms. While the tumors can be surgically removed or destroyed with radiation treatment, both approaches can also damage hearing.

Several previous investigations had suggested that – unlike other benign tumors – vestibular schwannomas induce the formation of new blood vessels, as malignant tumors do. A 2009 New England Journal of Medicine study led by Scott Plotkin, MD, PhD, at Massachusetts General Hospital reported that treatment with the antiangiogenesis drug bevacizumab caused shrinkage of NF2-schwannomas in most of the treated patients and improved hearing in more than half. But the limitations of that approach – the fact that not all patients responded, that the hearing improvement was often transient and that some patients could not tolerate long-term bevacizumab treatment – indicated the need to better understand the mechanisms of anti-angiogenesis on the function of tumor-bearing nerves.

Dr. Richardson: The International Nuclear Workers Study (INWORKS) combines three cohorts from France, the United Kingdom, and the United States of America. INWORKS follows on from an earlier 15-Country Study but focuses on the three countries that provided the majority of the most informative data on early nuclear workers (1940’s onward). The use of data from just 3 countries, instead of 15, reduces the organisational requirements – and therefore financial burden – associated with the greater number of countries but the cohort selection (of the three main contributing countries) means that the power of the INWORKS study is not a concern. INWORKS uses information from the French, UK and US cohorts that has been updated since the 15-Country study was published.

The overall purpose of the study is to improve the understanding of health risks associated with protracted, low-level exposure to ionising radiation.Continue reading →

Medical Research: What is the background for this study? What are the main findings?

Dr. Kantara: The increasing threats of radiation exposure and nuclear disasters have become a significant concern for the United States and countries worldwide. Such concern has increased national and international recognition for the need to develop novel medicinal countermeasures that can prevent radiation-induced tissue damage and keep thousands of people alive, even if administered a day or more after nuclear exposure. To date, there are only a few mitigating or radioprotective agents that are approved by the FDA, however they are unsuccessful in treating the gastrointestinal toxicity induced by high-dose radiation exposures, and are ineffective as a post-exposure treatment for the thousands of potential exposed individuals.

In our study, we showed that a single injection of TP508, administered 24 hours post-radiation, significantly increased mice survival and effectively protected the gastrointestinal mucosa by delaying crypt dissociation and directly stimulating stem cell regeneration. This suggests that TP508 may be an effective post-exposure medicinal countermeasure for mitigating radiation-induced gastrointestinal damage and mortality following a nuclear incident and may provide exposed victims additional time to be evacuated so that they can receive additional life-saving medical treatment.

Dr. Poortmans: Based on the former hypothesis that breast cancer sequentially spreads from breast to lymph nodes and from there to distant organs, up to the eighties it was very custom to perform extended radical surgery and to irradiate extensively locoregional for most patients. With the growing interest in systemic treatments to prevent development (= from already present undetectable cancer cells to really visible and threatening metastases) of distant metastases, new information about possible late side effects and our increasing knowledge about the biological behaviour of breast cancer in the eighties and the nineties, the extend of especially locoregional treatment was gradually reduced. For radiation therapy, often the irradiation of the internal mammary lymph nodes was left aside, as this was linked to the delivery of radiation dose to the heart, possibly or probably leading to late side effects. At the start of the study, about half of the radiation oncology departments did include irradiation of the internal mammary lymph nodes in patients with risk factors, while the other half did not. Hereby we had an ideal base for the investigation of the value of treating the non-operated part of the regional lymph nodes.

Dr. Shaitelman: Our study compared two different radiation therapy regimens for women with early stage breast cancer and examined the acute and short term toxicities associated with these two different treatments. The treatments compared a shorter versus a longer course of whole breast irradiation, both delivered with a tumor bed boost. Although prior published data supported giving a shorter course regimen, this was being used only in about one third of appropriate women in the United States, in part because of concerns regarding toxicities, restricted tumor enrollment in the earlier studies, as well as the earlier lack of incorporation of a tumor bed boost (which is standard and known to decrease the risk of tumor recurrence).

Medical Research: What are the main findings?

Dr. Shaitelman: A total of 287 patients were enrolled, age 40 years and older, with stage 0-II breast cancer. 76% of patients in the study were overweight or obese (in comparison with previous studies that had excluded patients with a larger body mass index). We found that during radiation treatment, women with the shorter course regimen had less breast pain, dermatitis, hyperpigmentation, and fatigue. At six months, by both physician assessment and patient report, patients treated with the shorter regimen had less fatigue. Patients treated with the shorter course regimen also reported having a better ability to care for the needs of their family compared to those patients treated with the longer course regimen.

Medical Research: What should clinicians and patients take away from your report?

Dr. Shaitelman: We believe that for women with early stage breast cancer, the shorter course regimen should be the starting point for discussions about whole breast radiation. As breast cancer outcomes continue to improve, focusing on how our treatments impact patients’ quality of life in both the short and long-term will be increasingly important.

MedicalResearch.com is not a forum for the exchange of personal medical information, advice or the promotion of self-destructive behavior (e.g., eating disorders, suicide). While you may freely discuss your troubles, you should not look to the Website for information or advice on such topics. Instead, we recommend that you talk in person with a trusted medical professional.

The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.

Medical Research: What is the background for this study? What are the main findings?

Response: In recent years, there has been accumulating evidence from clinical trials that have supported the long-term safety and effectiveness of shorter courses of radiation therapy—“hypofractionated radiation therapy”—for patients with breast cancer. However, little has been known about the experiences of patients during treatment, especially when this new approach is administered outside the setting of closely controlled clinical trials. Our study examined the side effects and patient-reported experiences during radiation treatment of over 2000 breast cancer patients in the state of Michigan. It found that women who received hypofractionated treatment were less likely to report side effects (including skin reaction and fatigue) than patients treated with more traditional courses of radiation treatment, delivered daily over 5-6 weeks or longer.

Medical Research: What is the background for this study? What are the main findings?

Dr. Henderson: A number of retrospective reviews of adjuvant radiotherapy after lymphadenectomy for patients at high risk of further lymph node field relapse had all suggested that the risk of lymph node field relapse was reduced but there was controversy about whether there was any impact on survival. In addition many clinicians were concerned about the side effects of radiotherapy and in the absence of a proven survival benefit were reluctant to recommend it. Previously a phase 2 trial of adjuvant radiotherapy conducted by one of our co-authors Prof Bryan Burmiester confirmed that the morbidity of lymph node field radiotherapy was limited and the risks of recurrence was reduced. On that basis the current ANZMTG TROG randomised multicentre trial was initiated.

In summary this final report updates information on overall survival, lymph node field relapse etc and provides information for the first time on long term toxicity of treatment, quality of life and lymphedema. Adjuvant lymph node field radiotherapy for patients at high risk of further lymph node field relapse reduces the risk of further lymph node field relapse by 50% but it has no effect on survival. Although radiotherapy toxicity was common (3 in 4 patients), mostly involving skin and subcutaneous tissue it was mild-to-moderate in severity and had little impact upon the patient’s quality of life as measured by the FACT-G quality of life tool. Specific regional symptoms were more common in the radiated group. Limb volume measurements confirmed a significant but modest increase for patients receiving inguinal radiation (15%) but not for axillary radiation.

In the design of this trial, a decision was made to allow patients in the observation arm who developed an isolated lymph node field relapse to be salvaged by surgery and or radiotherapy. There were only two patients in the radiotherapy arm who developed an isolated lymph node field relapse and both died of metastatic disease. In the observation arm 26 patients developed an isolated lymph node field relapse and the majority (23) achieved lymph node field control with a combination of surgery and or radiotherapy. The five-year survival FROM development of a lymph node field relapse in this group was 34% which is comparable to the overall survival of the entire cohort (42% five-year overall survival). This information whilst a subset analysis suggests that if it would be reasonable in some patients to consider a policy of observation only, reserving further surgery and or radiotherapy for a second relapse.

Medical Research: What is the background for this study? Response: Brain metastases are a serious complication of advanced malignancy and for most patients the objective is to maximise quality of survival. As treatment decisions become increasingly tailored to the individual, patient-focussed measures of efficacy such as neurocognitive function (NCF) are an important consideration. This is illustrated by the NCCTG N0574 randomised study reported last month at the American Society of Clinical Oncology (ASCO) 2015 Annual Meeting. 208 patients with 1-3 brain metastases each <3cm were randomised to stereotactic radiosurgery (SRS) or SRS with whole brain radiotherapy (WBRT). The addition of WBRT improved intracranial disease control but did not translate into a survival benefit and was associated with a decline in neurocognitive function at 3 months.

The objective of our study was to describe the types of changes in neurocognitive function that can occur, summarise how they are assessed and review approaches used to mitigate their effects. We wanted to provide busy physicians with a clear and comprehensive overview of the topic that could be used to inform clinical decisions.

Medical Research: What are the main findings?

Response: Using sensitive tests, most patients with brain metastases have deficits in neurocognitive function at diagnosis. Evaluating and understanding changes after treatment is complex because neurocognitive function is a dynamic process that is influenced by a long list of inter-related factors.

For patients treated using whole brain radiotherapy alone, worsening neurocognitive function is observed in about two-thirds within 2-6 months. Deficits in verbal memory and fine motor control are most common. It is unclear what proportion relates to treatment toxicity as opposed to disease progression or pre-terminal decline because both are unfortunately also common events during this interval. By contrast, in other patients, NCF improves after WBRT due to treatment response.

For patients with 1-4 brain metastases treated using SRS, the addition of WBRT improves intracranial disease control at the expense of deficits in verbal memory at 4 months but the impact of recurrence and salvage therapy on neurocognitive function later than this is uncertain. Scant data suggests that some deficits in neurocognitive function after WBRT may improve with time in long term survivors. For patients with ≥5 brain metastases, SRS and/or systemic therapies may be considered in select patients instead of upfront whole brain radiotherapy but high quality evidence is lacking.

Advanced radiotherapy technologies, such as hippocampal-sparing WBRT and post-operative cavity SRS, can limit the dose delivered to unaffected areas of the brain in the hope of reducing toxicity. Randomised studies assessing their efficacy and cost-effectiveness in various clinical situations are underway prior to routine use. Small but statistically significant improvements in certain neurocognitive domains can also be achieved using medications such as memantine and donepezil. Preclinical data suggests that some commonly available drugs (such as ramipril, lithium and indomethacin) may have neuroprotective properties following WBRT; further evaluation is warranted.

MedicalResearch: What is the background for this study? What are the main findings?

Dr. Leuraud: INWORKS was performed to quantify the risk of cancer mortality associated to protracted low doses of ionizing radiation typical of occupational or environmental exposures, as well as of diagnostic medical exposures. While such risks are well known for acute exposures as those experienced by the Japanese survivors of the A-bombs, there is still a lack of information for exposures experienced by the workers and the public. Our study confirms the existence of an association between leukemia mortality and chronic exposure to low doses received by nuclear workers.

Medical Research: What is the background for this study? What are the main findings?

Dr. Kamrava: Breast conservation (lumpectomy followed by radiation) is known, based on multiple randomized trials with over 20 years of follow-up, to provided equivalent outcomes as mastectomy. The radiation component of breast conservation has standardly been delivered to the whole breast. Studies show that the majority of breast recurrences occur near the lumpectomy cavity causing some to ask whether it is necessary to treat the whole breast in order to reduce the risk of a recurrence.

Partial breast radiation delivers treatment just to the lumpectomy cavity with a small margin of 1-2 cm. It’s delivered in a shorter time of 1 week compared with about 6 weeks for standard whole breast radiation and 3-4 weeks for hypofractionated whole breast radiation.

The original method developed to deliver partial breast radiation is interstitial tube and button brachytherapy. This uses multiple small little tubes that are placed through the lumpectomy cavity to encompass the area at risk. One end of these tubes can be connected to a high dose rate brachytherapy machine that allows a motorized cable with a very small radiation source welded to the end of it to be temporarily pushed in and out of each of the tubes so that the patient can be treated from “inside out”. This helps concentrate the radiation to the area of the lumpectomy cavity while limiting exposure to normal tissues. This treatment is most commonly delivered as an out-patient two times per day for a total of 10 treatments.

The main finding from our paper is that in reviewing the outcomes on over 1,000 women treated with this technique with an average follow-up of 6.9 years that the 10 year actuarial local recurrence rate was 7.6% and in women with more than 5 years of follow-up physician reported cosmetic outcomes were excellent/good in 84% of cases.

Medical Research: What is the background for this study? What are the main findings?

Dr. Zapatero: There is a significant body of evidence from randomized trials showing a significant improvement in clinical outcome with the combination of androgen deprivation and conventional-dose radiotherapy (≤70 Gy) in patients with high-risk and intermediate-risk prostate cancer. However, the optimal duration the optimum duration of androgen deprivation in the setting of high-dose radiotherapy remained to be determined.

The results of our trial (DART01/05) show that 2 years of adjuvant androgen deprivation is superior to 4 months androgen deprivation when combined with plus high-dose radiotherapy in terms of biochemical control, freedom from metastasis and overall survival, particularly in patients with high-risk prostate cancer.

Medical Research: What is the background for this study? What are the main findings?

Response: Stage IV Non-small cell lung cancer (NSCLC) remains a disease of limited survival, in the range of one year for a majority of patients who historically have gone on to receive systemic therapy only. Disease in this patient population most often recurs in the sites of original gross disease. With greater understanding of the biology and patterns of failure that occur in stage IV NSCLC, it is becomingly increasingly obvious that there are subsets of patients, those with limited sites of metastatic disease, who may benefit with more aggressive local therapy in addition to systemic agents to effectuate longer progression free survival (PFS) and potentially overall survival (OS). Since failures of treatment occur most commonly in original gross deposits, local non-invasive therapy in the form of stereotactic body radiation therapy (SBRT) may offer a means to curtail the recurrences, perhaps as a way to shift the time to and patterns of failure.

To address these concepts, a multi institutional single arm phase II study was conducted at UT Southwestern Medical Center in Dallas and University of Colorado Medical Center. Twenty-four patients with limited metastatic NSCLC (fewer than or equal to six sites of disease including the primary) who had progressed through at least one systemic therapy regimen were treated with SBRT to all sites of gross disease and the EGFR inhibitor erlotinib with progression free survival the primary end point. The results of the study were very significant, with a PFS in this study cohort of 14.7 months, compared to historical ranges of 2-4 months, and an OS of 20.4 months, compared to historical ranges of 6-9 months for this same patient population. The SBRT treatments were found to be very safe and efficacious – only 3 out of 47 measurable lesions irradiated recurred with a concomitant shift in failure patterns from local to distant sites. As importantly, EGFR status was evaluated in 13 patient tumors, with none harboring the most common mutations. One could, therefore, predict that with a mutation enriched population, the combination of EGFR inhibitor and SBRT may have offered even greater PFS and OS benefits. Our observations also suggest that the SBRT treatments probably contributed the most to the dramatic PFS and OS outcomes.

These findings were published in the Journal of Clinical Oncology in the December 1, 2014 print issue with an accompanying editorial.

Prof. Slotman: This randomized trial showed that the use of thoracic radiotherapy in patients with extensive stage small cell lung cancer reduces the risk of intrathoracic progression by about 50% and improves 2 years survival from 3 to 13%.

Answer: We use magnetic resonance imaging, a technology based on magnetic fields rather than radiotracers or x-rays. The underlying technology is not new – it has been used for tumor staging for many years. This is an advantage as MR scanners are available in nearly every major Children’s Hospital where children with cancer are treated. What is new about our approach is that we combined anatomical and functional images, similar to current approaches that use radiotracers and CT (PET/CT): We first acquired scans that showed the anatomy of the patient very well and we then acquired scans that depict tumors as bright spots with little or no background information. We did that by using an iron supplement as a contrast agent: The iron supplement can be detected by the MRI magnet and improved tumor detection and vessel delineation MR scans. We then fused the anatomical scans with the tumor scans.Continue reading →

Dr. Frank: The study found that the use of feeding tubes in oropharyngeal carcinoma (OPC) cancer patients treated with intensity modulated proton therapy (IMPT) decreased by more than 50% percent compared to patients treated with intensity modulated radiation therapy (IMRT). This suggests that proton therapy may offer vital quality of life benefits for patients with tumors occurring at the back of the throat.

Of the 50 OPC patients enrolled in the study:

Twenty-five patients were treated with IMPT and 25 received IMRT.

Five patients treated with IMPT required the use of feeding tubes (20%) compared to 12 patients treated with IMRT (48%).

IMPT patients were spared from serious side effects, usually a result of IMRT, such as loss of taste, vomiting, nausea, pain, mouth and tongue ulcers, dry mouth, fatigue, and swallowing difficulty.

IMPT patients could better sustain their nutrition and hydration levels, often leading to faster recovery during and after treatment.

IMPT is an advanced form of proton radiation therapy and a treatment currently only offered in North America at The University of Texas MD Anderson Proton Therapy Center. It delivers protons to the most complicated tumors by focusing a narrow proton beam and essentially “painting” the radiation dose onto the tumor layer by layer. Unlike IMRT, which destroys both cancerous and healthy cells, IMPT has the ability to destroy cancer cells while sparing surrounding healthy tissue from damage. Therefore, important quality of life outcomes such as neurocognitive function, vision, swallowing, hearing, taste and speech can be preserved in head and neck patients.Continue reading →

Answer: We investigated the cumulative radiation exposure and cancer risk of more than 1200 patients with ischemic heart diseases (IHD) from diagnostic and therapeutic imaging procedures performed 3 month before and 12 month after the date of diagnosis. The major findings were:

­ 87% of patient exposure resulted from heart catheter procedures.

­ The average cumulative effective dose was 13.3 mSv in males and 10.3 mSv in females. The highest dose was nearly 100 mSv.

­ The estimated average attributable life-time risk of male and female patients to develop a radiation-induced cancer in their remaining life was 0.09 % and 0.07 %, respectively. This correspond to 1 excess cancer in about 1100 male and 1400 female IHD patients. The highest risk was 0.9 %.

­ The effective dose is inadequate to characterize individual radiation risks, since neither the age nor the sex of the patient is taken into account. According to our results, cancer risks can vary by a factor of more than 10 for comparable values of the effective dose. Continue reading →

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MedicalResearch.com is not a forum for the exchange of personal medical information, advice or the promotion of self-destructive behavior (e.g., eating disorders, suicide). While you may freely discuss your troubles, you should not look to the Website for information or advice on such topics. Instead, we recommend that you talk in person with a trusted medical professional.

The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.